Web Content Viewer (JSR 286)

Web Content Viewer (JSR 286)

Food Safety and Inspection Service (FSIS) Statement of Interim Labeling Guidance Statements About Omega Fatty Acid Contents on the Labeling of Meat and Poultry Products

[This is an interim policy statement and may be withdrawn or modified if information is received by FSIS that shows that significant consumer confusion exists in this claims area.]

This policy documents that factual statements of the amount of omega-3 fatty acids per serving expressed either as the number of milligrams per serving or the number of grams per serving on labeling are acceptable. Similar factual statements regarding the amount of omega-6 fatty acids as well as the types of both omega-3 and omega-6 fatty acids (e.g., conjugated linoleic acid (CLA)) in a serving of a meat or poultry product will also be permitted. However, claims or implied claims regarding these components will not be permitted.

FSIS is aware that the increasing interest in making nutrient content claims regarding omega-3 fatty acid content or factual statements of the number of milligrams of omega-3 fatty acids has been increasing in the past several years. However, the nutrition labeling regulations in Title 9, Code of Federal Regulations (9 CFR), Subpart B, Section 317.300  317.400, for meat products, and Subpart Y, Sections 381.400  381.500, for poultry products, clearly state that claims that, expressly or by implication, characterize the amount of a nutrient in the product, may not be made on the labeling of a meat or poultry product unless the claim is made in accordance with the nutrition labeling regulations. Therefore, without regulations defining such claims, the labeling of meat and poultry products with express omega-3 fatty acid claims, including, but not limited to, Good Source of Omega-3 Fatty Acids, and Excellent Source of Omega-3 Fatty Acids, cannot be approved.

Similarly, labeling for meat and poultry products that bear claims that imply that the level of omega-3 fatty acids in a product is high or place significance on a specific level of Omega-3 Fatty Acids, including, but not limited to, Contains X grams Omega-3 Fatty Acids, More than X grams of Omega-3 Fatty Acids, and Fortified with X grams of Omega-3 Fatty Acids, cannot be approved. (Contains and provides are synonyms for good source claims). Similarly, trademarked uses of such phrases on labeling cannot be approved with the exception of the use of a company name in the signature line of a product label, provided that the signature line is normally placed and is not given undue prominence, which prominence would cause the use of the company name to be a false or misleading claim.

Historically, FSIS has permitted a factual statement on the number of grams of omega-3 fatty acids per serving on the labeling of meat and poultry products, provided that nutrition information was included on the labeling, data on the omega-3 fatty acid content was provided, and the product was not fortified to provide the omega-3 fatty acid content. The factual statements that have been approved have stated the number of grams of omega-3 fatty acids per serving rounded to the one tenth gram, e.g., 0.4 grams Omega-3 Fatty Acids per serving. The decision to only provide for factual statements declaring the grams of omega-3 fatty acids was based on discussions with other federal agencies and the Canadian Nutrition Labeling regulations which provides for the declaration of the number of grams of omega-3 fatty acids within the Canadian nutrition facts panel.

There is a growing interest in making factual statements based on the number of milligrams per serving, as opposed to the number of grams, which is the unit required for other fat declarations. This interest is possibly due to the desire to include such factual information on the labeling of products with smaller reference amounts where the level of omega-3 fatty acids per serving fall below 0.1grams per serving. After further evaluation of labeling requests about factual statements of the level of omega-3 fatty acids per serving based on milligrams per serving instead of grams per serving, and consulting with the Food and Drug Administration (FDA), Office of Nutritional Products, Labeling, and Dietary Supplements, FSIS has concluded that such declarations are not false or misleading . FDA also has no objection to factual statements about the level of omega-3 fatty acids declared in either grams or milligrams per serving. Therefore, FSIS believes that factual statements of the amount of omega-3 fatty acids per serving expressed either as the number of milligrams per serving or the number of grams per serving on labeling are acceptable. In addition, companies wishing to state the number of grams of omega-3 fatty acids per serving may declare the grams to the nearest one thousandth gram, e.g., 0.125 grams omega-3 fatty acids per serving. Similar factual statements regarding the amount of omega-6 fatty acids as well as the types of both omega-3 and omega-6 fatty acids (e.g., conjugated linoleic acid (CLA)) in a serving of a meat or poultry product will also be permitted.

Lastly, consistent with the Agencys regulations about generic label approval, all labels bearing special statements about the level of omega-3 fatty acids should be sent to the Agencys Labeling and Consumer Protection Staff for evaluation and approval before use.